Pharmacological properties of the drug Dalacin c
Pharmacodynamics. The active substance of the drug is clindamycin, a semisynthetic antibiotic that is synthesized from lincomycin by replacing the 7-(R)-hydroxyl group with 7-(S)-chloro. Depending on the sensitivity of the microorganism and the concentration, clindamycin can act bactericidal or bacteriostatic. In vitro active against microorganisms. Aerobic gram-positive cocci, including Staphylococcus aureus; Staphylococcus epidermidis (including strains that produce and do not produce penicillinase). During in vitro , rapid development of drug resistance was noted in some strains resistant to erythromycin; streptococci (except fecal streptococcus), pneumococci; anaerobic gram-negative bacteria, including Bacteroides spp. (including the B. fragilis, B. melaninogenicus ), Fusobacterium spp. ; anaerobic gram-positive non-spore-forming bacteria, including Propionibacterium, Eubacterium, Actinomyces spp. ; anaerobic and microaerophilic gram-positive cocci, including Peptococcus spp., Peptostreptococcus spp. , Microaerophylis streptococci ; Clostridium spp. Clostridia are more resistant to clindamycin than many other anaerobes. Most clostridia, especially Clostridium perfringens, are sensitive to clindamycin, but some species (eg C. sporogenes and C. tertium ) are often resistant to clindamycin. In this regard, it is necessary to test for sensitivity to the antibiotic. In vitro studies have shown that strains of microorganisms such as Bacteroides melaninogenicus, B. disiens, B. bivius, Peptostreptococcus spp., Gardnerella vaginalis, Mobiluncus mulieris, M. curtisii, Mycoplasma hominis . Pharmacokinetics. After oral administration of a dose of 150 mg of clindamycin hydrochloride, rapid and almost complete (90%) absorption of clindamycin occurs. The maximum level of the drug in the blood serum (2.5 μg/ml) is achieved after 45 minutes, after 3 hours the drug concentration is 1.51 μg/ml and after 6 hours - 0.7 μg/ml. After oral administration, almost complete (90%) absorption of clindamycin occurs; simultaneous food intake does not affect the concentration of clindamycin in the blood serum. A study of serum concentrations of the drug with prolonged use of clindamycin hydrochloride (for 14 days) did not reveal the accumulation of the drug or changes in its metabolism. The half-life of clindamycin is slightly increased in patients with significantly impaired renal function. Hemodialysis and peritoneal dialysis are not effective for removing clindamycin from the blood. Clindamycin serum concentrations increase linearly with increasing doses. The serum concentration of the drug already 6 hours after administration at the usual dose exceeds the minimum inhibitory concentration relative to most of the above-mentioned microorganisms. Clindamycin is widely distributed in tissues and body fluids (including bone tissue). The average biological half-life is 2.4 hours. About 10% of the active drug is excreted in the urine, 3.6% in feces, and the rest of the drug in the form of inactive metabolites. Clindamycin 2.0 g for 14 days was well tolerated by healthy volunteers, although an increase in gastrointestinal side effects was noted with increasing doses. In the CSF, even against the background of an inflammatory process, significant concentrations of clindamycin are not achieved. When administered orally, clindamycin hydrochloride was observed to increase the half-life to an average of 4 hours (range 3.4–5.1 hours) in elderly patients compared with 3.2 hours (range 2.1–5.1 hours) in younger patients. 4.2 hours). However, the degree of absorption in different age groups did not differ significantly, so there is no need to adjust the dose of the drug in elderly patients with normal (corresponding to age-related changes) liver and kidney function.
Dalatsin 300 mg No. 16 caps.
Instructions for medical use of the drug DALACIN® DALACIN® C PHOSPHATE Trade name DALACIN® DALACIN® C PHOSPHATE International nonproprietary name Clindamycin Dosage form Capsules of 150 mg and 300 mg Solution for injection 300 mg/2ml, 600 mg/4ml Composition Dalacin® capsules of 150 mg and 300mg: One capsule contains the active substance - clindamycin (in the form of clindamycin hydrochloride) 150 mg and 300 mg, excipients: lactose, magnesium stearate, corn starch, talc, gelatin, titanium dioxide. Dalatsin® C phosphate solution for injection: 1 ml of solution contains the active substance - clindamycin (in the form of clindamycin phosphate) 150 mg, excipients: benzyl alcohol, disodium edetate, water for injection. Description White hard gelatin capsules labeled “Clin 150” and “Pfizer” (for a dosage of 150 mg) or “Clin 300” and “Pfizer” (for a dosage of 300 mg) The contents of the capsules are homogeneous white powder. Dalacin® C phosphate solution for injection: clear, colorless solution. Pharmacotherapeutic group Antibacterial drugs of systemic action. Lincosamides. ATC code J01FF01 Pharmacological properties Pharmacokinetics Absorption After oral administration, almost complete (90%) absorption of clindamycin occurs. In adults, after oral administration of clindamycin at a dose of 150 mg, the maximum level of the drug in the blood serum (2.5 mcg/ml) is reached after 45 minutes. 3 hours after oral administration, the concentration of the drug in the blood serum is 1.5 mcg/ml, and after 6 hours it is 0.7 mcg/ml. After intramuscular administration of 600 mg of clindamycin phosphate, the maximum concentration of the drug in the blood serum (9 μg/ml) is achieved 1-3 hours from the moment of administration. After intravenous infusion of 300 mg of the drug over 10 minutes or 600 mg of the drug over 20 minutes, the maximum concentration of the drug, which is 7 μg/ml and 10 μg/ml, respectively, is achieved at the end of the drug administration. Clindamycin phosphate is prescribed to adults every 8-12 hours, to children - every 6-8 hours, or as a continuous intravenous infusion, which provides clindamycin serum concentrations that exceed the minimum in vitro concentration of the drug necessary to suppress the most sensitive to clindamycin microorganisms. A constant level of the drug in the body is achieved after the third dose. The distribution of 40-90% of the administered drug is bound in the body to blood proteins. After oral administration, accumulation of the drug in the body is not observed. Clindamycin easily penetrates into most tissues and body fluids. The concentration of clindamycin in bone tissue reaches approximately 40% (20-75%) of the drug concentration in the blood serum. In breast milk, the concentration of the drug is 50-100% of the concentration in blood serum, in synovial fluid 50%, in fetal blood 40%, in pus 30%, in pleural fluid 50-90% of the concentration in blood serum. Clindamycin does not cross the blood-brain barrier, even in cases of meningitis. Metabolism The half-life of clindamycin is + 1.5-3.5 hours. In patients with severely impaired liver and/or kidney function, this period may be prolonged. If you have mild or severe kidney or liver disease, the treatment regimen does not need to be changed. Clindamycin is almost completely metabolized. Excretion In the active form, 10-20% of the drug is excreted from the body by the kidneys, 4% - with feces. The remaining amount is excreted as inactive metabolites, mainly in bile and feces. Pharmacodynamics The active substance of the drug is clindamycin, a semi-synthetic substance with antimicrobial activity, which is formed from lincomycin by replacing the 7-(R)-hydroxyl group with 7-(S)-chloro. Depending on the sensitivity of the microorganism and the concentration of the drug, clindamycin can act bactericidal or bacteriostatic. In vitro, clindamycin has an effect on the following isolated forms of microorganisms: 1) Aerobic gram-positive cocci, including: · Staphylococcus aureus · Staphylococcus epidermidis (strains that produce and do not produce penicillinase). During in vitro studies, rapid development of resistance to clindamycin was observed in some staphylococcal strains resistant to erythromycin. · Streptococci (except fecal streptococcus) · Pneumococci 2) Anaerobic gram-negative bacilli, including: · Bacteroides species (including the B.fragilis group and the B.meleninogenicus group) · Fusobacterium species 3) Anaerobic gram-positive bacilli that do not form spores, including: · Propionibacterium · Eubacterium · Actinomyces species 4) Anaerobic and microaerophilic gram-positive cocci, including: · Peptococcus species · Peptostreptococcus species · Microaerophilic streptococci · Clostridia: Clostridia are more resistant to clindamycin than most other anaerobes. Most Clostridium perfringens are sensitive to clindamycin, but other species, such as C. sporogenes and C. tertium, are often resistant to clindamycin. Therefore, it is necessary to conduct sensitivity tests. 5) Various organisms, including Chlamidia trachomatis, Toxoplasma gondii, Plasmodium falciparum and Pneumocystis carinii (in combination with primaquine), Gardnerella vaginalis, Mobiluncus mulieris, Mobiluncus curtisii, Mycoplasma hominis. The following organisms are commonly resistant to clindamycin: Aerobic gram-negative bacilli Streptococcus faecalis Nocardia species Neisseria meningitidis Methicillin-resistant Staphylococcus aureus strains and Haemophilus influenzae strains Cross-resistance exists between lincomycin and clindamycin. There is antagonism between clindamycin and erythromycin. Although clindamycin hydrochloride is active both in vitro and in vivo, clindamycin phosphate and clindamycin palmitate are inactive in vitro. However, both compounds are rapidly hydrolyzed to the active base in vivo. Indications for use Dalatsin® is effective in the treatment of the following infections if they are caused by susceptible anaerobic bacteria or strains of gram-positive aerobic bacteria such as streptococci, staphylococci and pneumococci, as well as clindamycin-sensitive species of Chlamidia trachomatis: - upper respiratory tract infections, including: tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever - infections of the lower respiratory tract, including: bronchitis, pneumonia, pleural empyema and lung abscess - infectious diseases of the skin and soft tissues, including: acne, boils , cellulite, impetigo, abscesses, infected wounds, specific infectious processes of the skin and soft tissues caused by pathogens sensitive to this drug, such as erysipelas and paronychia (felon) - infectious diseases of bones and joints, including: osteomyelitis and septic arthritis - gynecological infections, including endometritis, tubal and ovarian abscesses, salpingitis and pelvic inflammatory disease, when prescribed in combination with a suitable antibacterial drug active against gram-negative aerobic pathogens. In the case of cervical infections caused by Chlamidia trachomatis, drug therapy exclusively with Dalatsin® has been shown to be effective for complete cure - infectious diseases of the abdominal cavity, including: peritonitis and abdominal abscesses (in combination with other antibacterial drugs that act on gram-negative aerobic bacteria) - septicemia and endocarditis. The effectiveness of the drug Dalacin® has been proven in certain cases of endocarditis: the drug has a bactericidal effect on the infectious agent in vitro when using such concentrations of the drug that are achieved in human blood serum. - oral infections such as periodontal abscess and periodontitis - toxoplasma encephalitis in patients with AIDS. The effectiveness of the drug in combination with pyrimethamine has been proven in patients with intolerance to standard therapy - Pneumocystis pneumonia in patients with AIDS. In patients intolerant or resistant to standard therapy, Dalatsin® can be used in combination with primaquine - malaria, including that caused by multidrug-resistant Plasmodium falciparum, both as monotherapy and in combination with quinine or chloroquine - prevention of endocarditis in patients with hypersensitivity to penicillins - prevention of infections during operations in the head and neck area. Dalacin® C phosphate, diluted in saline solution, is used in surgery to irrigate the surgical wound - early administration of the drug Dalacin® C phosphate in combination with an antibacterial drug from the aminoglycoside group, for example gentamicin or tobramycin, successfully prevents the development of peritonitis or abdominal abscess after perforation intestines or as a result of traumatic infection In vitro studies have shown that the following strains of microorganisms are sensitive to clindamycin: B.melaninogenicus, B.disiens, B.bivius, Peptostreptococcus spp., G.vaginalis, M.mulieris, M.curtisii, Mycoplasma hominis To avoid complications, use strictly as prescribed by your doctor. Method of administration and dosage Adults and children over 12 years of age Dalatsin® C phosphate (intravenously or intramuscularly): For the treatment of infectious diseases of the abdominal cavity, inflammatory diseases of the pelvic organs in women, as well as for other complicated or severe infections, 2400-2700 mg of the drug is usually prescribed per dose. day, divided into 2, 3 or 4 equal doses. In milder forms of infection and in the presence of a pathogen more sensitive to therapy, the therapeutic effect is achieved by prescribing smaller doses of the drug - 1200-1800 mg/day, divided into 3 or 4 equal doses. Doses of the drug reaching 4800 mg/day have been used with success. It is not recommended to administer intramuscularly a single dose exceeding 600 mg. Dalatsin® capsules (orally): 600-1800 mg/day in 2, 3 or 4 divided doses (equal doses). To avoid irritation of the esophageal mucosa, capsules should be taken with a full glass of water. Children over 1 month Dalatsin® C phosphate (intravenous or intramuscular): 20-40 mg/kg body weight/day, divided into 3 or 4 equal doses. It is administered as an infusion, the solvent is saline solution. Newborns (under 1 month) Dalacin® C phosphate (intravenous or intramuscular): 15-20 mg/kg body weight/day, divided into 3 or 4 equal doses. It is administered as an infusion, the solvent is saline solution. For premature babies, a lower dose of the drug may be sufficient. Selected indications Infections caused by beta-hemolytic streptococcus: doses are indicated above, treatment should be continued for at least 10 days. Pelvic inflammatory diseases: 900 mg of Dalacin® C phosphate IV every 8 hours + IV a suitable antibacterial agent active against gram-negative aerobic pathogens (for example, gentamicin at a dose of 2.0 mg/kg followed by 1.5 mg /kg every 8 hours for patients with normal renal function). Continue IV medications for at least 4 days and then for at least 48 hours after the patient's condition improves. Then take 450-600 mg of Dalacin® orally every 6 hours until the 10-14 day course of therapy is completed. Cervical infections caused by Chlamidia trachomatis: 450-600 mg of Dalatsin® orally 4 times a day for 10-14 days. Toxoplasma encephalitis in patients with AIDS: in patients with intolerance to standard therapy, Dalacin® C phosphate or Dalacin® is used in combination with pyrimethamine according to the following regimen: Dalacin® C phosphate IV or Dalacin® orally at a dose of 600-1200 mg every 6 hours for 2 weeks, and pyrimethamine at a dose of 25-75 mg orally every day. Typically the course of therapy is 8-10 weeks. When using higher doses of pyrimethamine, folinic acid should be prescribed at a dose of 10-20 mg/day. Pneumocystis pneumonia in patients with AIDS: Dalacin® C phosphate IV 600-900 mg every 6 hours or 900 mg IV every 8 hours, or Dalacin® 300-450 mg orally every 6 hours for 21 days and primaquine 15- 30 mg orally once daily for 21 days. Acute streptococcal tonsillitis/pharyngitis: Dalatsin® 300 mg orally 2 times a day for 10 days. Malaria: Dalatsin® capsules 10-20 mg/kg/day for adults and 10 mg/kg/day for children every 12 hours in equal doses for 7 days as monotherapy, or in combination with quinine (12 mg/kg every 12 hours ) or chloroquine (15-25 mg every 24 hours) for 3-5 days. Prevention of endocarditis in patients with hypersensitivity to penicillin: 600 mg capsules orally for adults and 20 mg/kg for children 1 hour before taking penicillin; or Dalacin® C phosphate IV at a dose of 600 mg 1 hour before penicillin administration. Prevention of infections during operations in the neck and head: Dalatsin® C phosphate (900 mg in 1 liter of saline) is used during surgery to irrigate contaminated wounds of the head and neck before closing the wound. Dilution and infusion rate The concentration of clindamycin in the solution for infusion should not exceed 18 mg/ml and the infusion rate should not exceed 30 mg/min. The following infusion rates are typically used: Clindamycin dose Volume of saline Time 300 mg 600 mg 900 mg 1200 mg 50 ml 50 ml 50-100 ml 100 ml 10 min 20 min 30 min 40 min Administration of more than 1200 mg in a single 1-hour infusion is not recommended . Side effects - abdominal pain, nausea, vomiting and diarrhea, and with oral use - esophagitis (in addition to the above reactions) - hypersensitivity reactions. In some cases, maculopapular rash and urticaria are noted. A generalized morbilliform rash of mild to moderate severity is the most common adverse reaction. Rare cases of erythema multiforme resembling Stevens-Johnson syndrome, as well as cases of anaphylactoid reactions. - phenomena of jaundice and liver dysfunction - itching, vaginitis, as well as rare cases of exfoliative and vesicular-bulous dermatitis - neutropenia (leukopenia) and eosinophilia of a passing nature, as well as cases of agranulocytosis and thrombocytopenia, but it was not possible to establish an etiological connection between these phenomena and the therapy with the drug Dalacin® - with too rapid intravenous administration of the drug, cases of respiratory and cardiac arrest, as well as the development of hypotension have been observed - with intramuscular administration of the drug, phenomena such as local irritation, pain and the formation of abscesses in the area of injection may be observed. When administered intravenously, thrombophlebitis sometimes occurred. The incidence of such phenomena decreases when the drug is administered deeply intramuscularly and with the rarest possible use of permanent intravenous catheters. Contraindications - hypersensitivity to clindamycin, lincomycin or any component of the drug Drug interactions The following drugs are physically incompatible with Dalatsin® C phosphate in solution for infusion: ampicillin, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, magnesium sulfate, ceftriaxone sodium, ciprofloxacin. It was found that in vitro antagonism occurs between clindamycin and erythromycin. Because this antagonism may be clinically significant, the two drugs should not be administered simultaneously. Clindamycin has been found to interfere with neuromuscular transmission, so it may enhance the effect of other peripherally acting muscle relaxants. Therefore, it should be used with caution in patients receiving drugs in this group. Special instructions Dalatsin® C phosphate injection solution contains benzyl alcohol. There are reports that benzyl alcohol can cause the development of fatal Gasping Syndrome (respiratory problems manifested by suffocation) in premature newborns. Cases of pseudomembranous colitis of varying severity, even life-threatening, have been observed with the use of almost all antibacterial agents, including Dalatsin®. Therefore, in all cases of diarrhea after taking antibacterial drugs, this diagnosis should be considered. Antibacterial drugs suppress the normal intestinal flora, which can contribute to increased proliferation of clostridia. Toxins produced by Clostridium difficile have been shown to be a major cause of antibiotic-associated colitis. After making a diagnosis of pseudomembranous colitis, the following measures must be taken: in mild cases, it is usually sufficient to discontinue the antibacterial agent; In moderate to severe cases, consideration should be given to fluid, electrolyte, protein, and an antibacterial drug effective against Clostridium difficile. Dalacin® should not be prescribed for the treatment of meningitis, since clindamycin does not penetrate the blood-brain barrier well. If treatment is carried out over a long period of time, liver and kidney function tests should be carried out regularly. When using antibacterial agents, including Dalatsin®, excessive growth of microorganisms that are insensitive to this drug, especially yeast-like fungi, is possible. Dalacin® C phosphate should not be administered intravenously and at the same time. Infusion must be carried out for at least 10-60 minutes. There are no recommendations for reducing the dose of Dalacin® in patients with impaired liver and kidney function. Pregnancy and breastfeeding clindamycin penetrates through the placenta. After the introduction of several doses of the drug, the concentration in amniotic fluid was approximately 30% of the concentration in the blood of the mother. Dalacin® should be used in pregnant women only according to absolute indications, i.e. When the potential benefits of therapy with the drug surpasses potential risk. It was reported that clindamycin is found in breast milk at a concentration of 0.7-3.8 μg/ml. Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms were not studied. Overdose symptoms: strengthening side effects. Treatment: symptomatic and supportive. The form of release and packaging Dalacin® Capsules: · Blisters of 8 capsules · 2 blisters and instructions for use are packed in a cardboard pack. Dalacin® C phosphate injection solution: · ampoules made of transparent glass of 2 ml, 4 ml; · 1 ampoule and instructions for use are packed in a cardboard pack. Storage conditions are stored at a temperature of not higher than +25 ° C. Keep out of the reach of children! The shelf life of the capsule is 5 years in injection - 2 years cannot be used after expiration of the shelf life. Conditions of pharmacies according to the recipe manufacturer capsule: Pfizer PGM Zone Industrielle-29 Route des Industries 37530 POCE-SUR-CISSE FRANCE A solution for injections: PFIZER MFG Belgium N.V. Rijksweg 12, 2870 Puurs Belgium
Indications for use of the drug Dalacin c
Dalatsin C and Dalatsin S Phosphate is an effective remedy in the treatment of infections caused by pathogens sensitive to it:
- infections of the ENT organs, including pharyngitis, sinusitis, otitis media, scarlet fever;
- lower respiratory tract infections, including bronchitis, pneumonia, lung abscess, pleural empyema;
- infections of the skin and soft tissues, including acne, furunculosis, cellulitis, impetigo, abscesses, infected wounds, specific infectious processes of the skin and soft tissues caused by pathogens sensitive to this drug, such as erysipelas and paronychia/felon;
- infections of bones and joints, including osteomyelitis and purulent arthritis;
- gynecological infections, including endometritis, phlegmon, colpitis, tubo-ovarian abscesses, salpingitis and pelvic inflammatory diseases, if the drug is prescribed in combination with an appropriate antibiotic active against gram-negative pathogens. For cervical infections caused by Chlamydia trachomatis , clindamycin monotherapy is effective in eradicating this organism;
- intra-abdominal infections, including peritonitis and abscesses of the abdominal organs (in combination with antibiotics acting on gram-negative aerobes);
- septicemia and endocarditis. The effectiveness of clindamycin has been proven in certain cases of endocarditis: the drug has a bactericidal effect on the infectious agent in vitro when using such concentrations of the drug that are achieved in human blood serum;
- oral infections, including periodontal abscess and periodontitis;
- toxoplasmic encephalitis in patients with AIDS (the effectiveness of clindamycin in combination with pyrimethamine has been proven in patients intolerant to standard therapy);
- Pneumocystis pneumonia in patients with AIDS (in patients who cannot tolerate or are resistant to standard therapy, clindamycin can be used in combination with primaquine);
- malaria, including cases caused by multidrug-resistant Plasmodium falciparum (as monotherapy or in combination with quinine or chloroquine);
- prevention of endocarditis in patients with hypersensitivity to penicillins;
- prevention of wound infection during surgical interventions in the head and neck area;
- prevention of peritonitis and intra-abdominal abscesses after perforation and post-traumatic contamination when used simultaneously with aminoglycoside antibiotics (gentamicin or tobramycin).
Dalacin C 150 mg No. 16 Capsules
Active ingredient : Clindamycin
Pharmacological action: The active ingredient of the drug is clindamycin, an antibiotic of the lincosamide group. The drug is synthesized by sulfonation of lincomycin. Clindamycin has a bactericidal and bacteriostatic effect due to disruption of protein metabolism in the ribosomal membrane of microorganisms. Depending on the sensitivity of certain strains of microorganisms and the dose of the active substance, clindamycin has a bacteriostatic or bactericidal effect. The drug is active against gram-positive aerobic and anaerobic bacteria. Including: Staphylococcus spp., Streptococcus spp., Bacillus anthracis, Corynebacterium diphteriae, Nocardia asteroids. The drug also has an antimicrobial effect against Actinomyces spp., Bacteroides spp., Clostridium spp., Eubacterium spp., Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp., Porphyromonas spp., Prevotella melaninogenica, Propionibacterium acnes. Chlamidia trachomatis, Leptospirae, Mycoplasma spp., Plasmodium falciparum, Toxoplasma gondii are sensitive to the action of clindamycin. Gram-negative microorganisms and strains that are resistant to lincomycin are insensitive to the drug. After oral administration of the drug, absorption from the gastrointestinal tract reaches 90%; the rate of absorption is not affected by food intake. The drug is quickly absorbed into the general bloodstream, the maximum concentration in the blood plasma is achieved within 45-60 minutes. The half-life of the drug is 2-4 hours. In elderly patients and patients suffering from impaired renal function, the half-life may increase to 5 hours. The drug penetrates well into all biological fluids and human organs, including saliva, bronchial secretions, appendix, fallopian tubes, liver, gall bladder. High concentrations of the drug are observed in bone tissue. Clindamycin penetrates the blood-placental barrier and is excreted in significant concentrations in breast milk. The drug does not penetrate the blood-brain barrier and is not detected in the cerebrospinal fluid even with meningitis. Clindamycin is metabolized in the liver, excreted primarily in the urine, and some is excreted in the feces. Less than 10% of the drug is excreted from the body unchanged, the rest in the form of unchanged metabolites is excreted mostly in the feces. The drug is not excreted by hemodialysis and peritoneal dialysis. There is no accumulation or changes in the metabolism of the drug due to long-term use.
Indications for use: The drug in oral dosage forms is prescribed to patients for diseases caused by microorganisms sensitive to clindamycin: - infectious diseases of the ENT organs and respiratory tract, including otitis, sinusitis, pharyngitis, pneumonia, bronchitis, as well as lung abscess and pleural empyema; - infectious diseases of the skin, soft tissues, bones and joints, including furunculosis, acne, impetigo, abscesses, erysipelas, infected wounds, osteomyelitis, arthritis, including purulent arthritis; — infectious diseases of the genitourinary system in women, including endometritis, colpitis, phlegmon, salpingitis, cervical infections; - intra-abdomial infectious diseases, including abdominal abscesses and peritonitis (in the treatment of these diseases it is recommended to combine clindamycin with an antibiotic that is effective against gram-negative microorganisms); the drug is also used in the treatment of endocarditis and septicemia; — infectious diseases of the oral cavity, including periodontal abscess and periodontitis; — dalacin is also used in the treatment of patients with malaria, including that caused by Plasmodium falciparum; — the drug is used to prevent endocarditis in patients with penicillin intolerance; — for the prevention of infectious diseases during surgical interventions in the head and neck area; — for the prevention of peritonitis and intra-abdominal abscesses, Dalatsin is used in combination with aminoglycoside antibiotics.
Directions for use: Dalacin C capsules for oral use: The duration of treatment and dose of the drug is determined by the attending physician, individually for each patient, taking into account age, severity of the disease, the presence of concomitant diseases and other factors. The drug is taken without chewing, preferably at the same time as a meal, and washed down with plenty of water. Adults are usually prescribed 150 mg 4 times a day at regular intervals. In case of severe infections, the dose can be increased to 300-450 mg 4 times a day at regular intervals. For infections caused by Chlamydia trachomatis, including infectious diseases of the cervix, 450 mg is prescribed every 6 hours. The course of treatment is 2 weeks. For children, the dose is calculated taking into account body weight, usually prescribed in a daily dose of 8-25 mg/kg body weight, the dose is divided into 4 doses. The course of treatment is determined by the attending physician, however, it is worth considering that for streptococcal infections it is necessary to take clindamycin for at least 10 days.
Side effects : When taking the drug Dalacin C, the following side effects may develop:
From the gastrointestinal tract: pain in the epigastric region, nausea, vomiting, diarrhea, esophagitis, disturbance of intestinal microflora. In addition, esophageal ulcers may develop when taking the drug orally.
From the hematopoietic system: eosinophilia, agranulocytosis, leukopenia, thrombocytopenia.
From the skin and mucous membranes: urticaria, skin rash, itching, maculopapular rash, vaginitis, toxic epidermal necrolysis, Stevens-Johnson syndrome.
From the nervous system: it is extremely rare to develop disorders of neuromuscular conduction.
Allergic reactions: anaphylactoid reactions, up to anaphylactic shock (with rapid administration).
Other side effects: with rapid administration of the drug, patients experience hypertension, apnea, weakness, and dizziness.
Contraindications: - Individual hypersensitivity to the components of the drug and antibiotics of the lincosamide group; - severe dysfunction of the liver and kidneys; - children up to 1 month; - colitis caused by the use of antibacterial drugs, including in history; - period of pregnancy and lactation.
Pregnancy : There is no reliable data on the safety of using the drug Dalacin C and Dalacin C Phosphate in pregnant women, therefore the drug is prescribed only for health reasons. If it is necessary to use the drug in nursing women, it is recommended to temporarily stop breastfeeding.
Drug interactions: The drug is not prescribed simultaneously with erythromycin, ampicillin, barbiturates, calcium gluconate, aminophylline, magnesium sulfate. When using the drug simultaneously with antidiarrheals, the risk of developing pseudomembranous colitis increases. The drug enhances the effect of muscle relaxants, so the simultaneous use of these drugs should be under the supervision of a physician.
Overdose: Cases of overdose have not been described. With the development of anaphylactic reactions, the administration of glucocorticosteroids, adrenaline and antihistamines is indicated. There is no specific antidote. Hemodialysis is ineffective.
Release form: Dalacin C capsules, 150 mg of active ingredient, 8 capsules in a blister, 2 blisters in a cardboard package.
Storage conditions: It is recommended to store the drug in a dry place at a temperature of 15 to 25 degrees Celsius.
Shelf life: 5 years.
Composition: 1 capsule Dalacin C 150 mg contains: Clindamycin – 150 mg; Excipients, including lactose.
Pharmacological group: Antimicrobial and antiparasitic agents
Use of the drug Dalacin c
The dose and method of administration of the drug depend on the severity of the disease, the patient’s condition and the sensitivity of the infectious agent to the antibiotic. The course of treatment lasts on average 7–10 days. Adults Dose of Dalacin C in capsule form for oral use: 600–1800 mg per day, divided into 2, 3 or 4 equal doses. In order to prevent possible irritation of the esophagus, Dalacin C capsules should be taken with a full glass of water. Capsules should not be opened. Children over 6 years of age The dose of Dalacin C is 8-25 mg/kg per day in 3-4 doses. To avoid irritation of the esophageal mucosa, capsules should be taken with a full glass of water. Elderly patients No dosage adjustment is required in elderly patients with normal liver and kidney function. Patients with renal failure Patients with renal failure do not require dose adjustment. Patients with liver failure Patients with liver failure do not require dose adjustment.
Special instructions for the use of Dalacina C
for selected indications Treatment of infections caused by β-hemolytic streptococcus. For infections caused by β-hemolytic streptococcus, treatment must be continued for at least 10 days. Treatment of acute streptococcal tonsillitis/pharyngitis. The dose of Dalacin C in capsules for oral use is 300 mg 2 times a day for 10 days. Treatment of inflammatory diseases of the pelvic organs. After parenteral administration of the drug for 6 days, clindamycin hydrochloride should be continued orally at a dose of 450–600 mg every 6 hours until completion of the 10–14 day therapy cycle. Cervical infections caused by Chlamydia trachomatis 450–600 mg Dalacin C orally 4 times a day for 10–14 days. Toxoplasmosis encephalitis in patients with AIDS. Dalacin C orally at a dose of 600–1200 mg every 6 hours for 2 weeks, then 300–600 mg orally every 6 hours. The course of therapy is usually 8–10 weeks. The dose of pyrimethamine is 25–75 mg orally daily for 8–10 weeks. When using pyrimethamine in higher doses, folinic acid should be prescribed at a dose of 10–20 mg/day. Pneumocystis pneumonia in patients with AIDS. Dalacin C 300–450 mg orally every 6 hours for 21 days and primaquine 15–30 mg orally once a day for 21 days. Treatment of malaria. Adults are prescribed at a dose of 10–20 mg/kg per day, children - 10 mg/kg per day in equal doses 2 times a day for 7 days as monotherapy or in combination with quinine (12 mg/kg 2 times a day) or chloroquine (15–25 mg once daily) for 3–5 days. Prevention of endocarditis in patients with hypersensitivity to penicillin. Adults are prescribed 600 mg 1 hour before surgery or a therapeutic and diagnostic procedure (for example, tonsillectomy, adenoidectomy, bronchoscopy with a rigid bronchoscope, dilation of esophageal stricture, retrograde cholangiopancreatography, cystoscopy, etc.); children - 20 mg/kg 1 hour before surgery or diagnostic and treatment procedures.
Side effects of the drug Dalacin c
blood and lymphatic system: transient neutropenia/leukopenia, eosinophilia, agranulocytosis, thrombocytopenia (no clear cause-and-effect relationship with the use of Dalacin C has been established); immune system: anaphylactoid reactions; nervous system: dysgeusia; Gastrointestinal tract: abdominal pain, nausea, vomiting, diarrhea, esophagitis, esophageal ulcer; hepatobiliary disorders: jaundice, changes in liver function tests (including hyperbilirubinemia); skin, subcutaneous tissue and mucous membranes: maculopapular rash, urticaria, mild or moderate generalized rash, erythema multiforme, Stevens-Johnson syndrome, itching, vaginitis, exfoliative and vesiculobullous dermatitis, toxic epidermal necrolysis.
Buy Dalatsin vaginal cream 2% 40g No. 7 in pharmacies
Instructions for use Dalatsin
Buy Dalatsin cream for external use 2% 40g No. 7
Dosage forms vaginal cream 2% Manufacturers Pharmacy and Upjohn Company (United States of America) Group Antibiotics of the lincomycin group Composition Active ingredient - clindamycin. International nonproprietary name Clindamycin Synonyms Zerkalin, Clindamycin, Klindafer, Clindacin, Klindovit Pharmacological action Antibacterial. Binds to the 50S subunit of the ribosomal membrane and inhibits protein synthesis in microorganisms. It is quickly and completely absorbed into the gastrointestinal tract; simultaneous food intake slows down absorption without changing the completeness. Easily penetrates biological fluids and tissues; passes through the blood-brain barrier (BBB) poorly. After intramuscular administration, the maximum concentration in the blood is reached after 2-2.5 hours, in a therapeutic concentration it circulates in the blood for 8-12 hours, the half-life is 2.4 hours; metabolized in the liver, most of the active and inactive metabolites are excreted within 4 days in the urine, a smaller part is excreted through the intestines. Refers to reserve antibiotics that suppress gram-positive cocci (staphylococci, streptococci, pneumococci), incl. producing penicillinase, as well as mycoplasmas, bacteroides, fusobacteria, actinomycetes, some strains of Haemophilus influenzae, causative agents of anthrax, gas gangrene and tetanus. According to the mechanism of action and antimicrobial spectrum, it is close to lincomycin. Indications for use Infections of the upper and lower respiratory tract (pharyngitis, tonsillitis, scarlet fever, diphtheria, sinusitis, otitis, pneumonia, including aspiration, lung abscess, bronchitis), abdominal cavity (peritonitis, abscess), oral cavity, urogenital area (chlamydia, endometritis, vaginal infections, tubo-ovarian inflammation), skin and soft tissues (infected wounds, abscesses), acute and chronic osteomyelitis, septicemia, bacterial endocarditis, acne (externally). Contraindications Hypersensitivity, myasthenia gravis, lactation. Restrictions on use: Severe liver and kidney dysfunction, infancy (up to 1 month), pregnancy. Side effects Dyspepsia (abdominal pain, nausea, vomiting, diarrhea), esophagitis, liver dysfunction, jaundice, dysbacteriosis (clostridial pseudomembranous colitis), allergic reactions (urticaria, erythema), leukopenia, neutropenia, eosinophilia, thrombocytopenia, hyperbilirubinemia. At the injection site there is irritation, pain, infiltrates and abscesses, thrombophlebitis. With rapid intravenous administration - cardiovascular failure (collapse, cardiac arrest), arterial hypotension. Interaction Incompatible with erythromycin, ampicillin, diphenylhydantoin, barbiturates, aminophylline, calcium gluconate and magnesium sulfate. Strengthens (mutually) the effect of rifampicin, aminoglycosides - streptomycin, gentamicin. Deepens muscle relaxation caused by n-cholinergic blockers. Co-administration with antidiarrheal drugs increases the risk of developing pseudomembranous colitis. Simultaneous use with solutions containing B complex vitamins is not recommended. Method of application and dosage Externally. A thin layer of gel is applied to the affected area of clean, dry skin 2 times a day. To obtain satisfactory results, treatment should be continued for 6-8 weeks, and if necessary, can be continued for up to 6 months. Overdose No data available. Special instructions No data available. Storage conditions At a temperature of 20-25 °C. List B.
Special instructions for the use of the drug Dalacin c
Treatment with clindamycin, like other antibiotics, may be complicated by the development of pseudomembranous colitis. Therefore, it is important to promptly diagnose this pathology in patients with diarrhea while using antibacterial agents and discontinue the drug. Antibacterial drugs inhibit the functioning of the normal flora of the large intestine, which can cause rapid proliferation of clostridia. The results of the studies indicate that toxins produced by clostridia, especially Clostridium difficile , are the most important and direct cause of the development of colitis. If pseudomembranous colitis develops, appropriate treatment should be prescribed. In mild cases of pseudomembranous colitis, discontinuation of clindamycin may be sufficient. With the development of a moderate and severe form, it is necessary to carry out appropriate therapy, which includes the use of fluids, solutions of electrolytes and protein preparations and the use of drugs that are effective against the pathogen - Clostridium difficile . Clindamycin should not be used to treat meningitis because the drug does not penetrate the CSF well. With long-term treatment with antibacterial drugs, it is necessary to monitor liver and kidney function. As a result of clindamycin therapy, microflora that are insensitive to this drug, especially yeast, may be activated. Cases of diarrhea associated with Clostridium difficile have been reported with the use of almost all antibacterial agents, including clindamycin. The severity of diarrhea can range from moderate to severe fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to an increase in Clostridium difficile . C. difficile produces exotoxins A and B, which cause Clostridium difficile -associated diarrhea. Toxin-overproducing strains of C. difficile cause increased morbidity and mortality because these infections may be refractory to antibiotic therapy; Sometimes a colectomy may be necessary. In patients who have developed diarrhea syndrome during the use of antibiotics, it is necessary to exclude the possibility of developing Clostridium difficile -associated diarrhea. Careful monitoring and maintenance of the patient's medical records is necessary from the moment of reporting the occurrence of Clostridium difficile -associated diarrhea until 2 months after the use of antibacterial agents. During pregnancy and breastfeeding. Clindamycin is able to cross the placenta. With long-term use, the level of clindamycin in amniotic fluid is about 30% of the drug concentration in the mother's blood. Dalatsin C can be prescribed during pregnancy only in case of urgent need. Clindamycin has been reported to pass into breast milk at concentrations of 0.7–3.8 mcg/ml. It is recommended to stop breastfeeding while using Dalatsin C. Impact on the ability to drive vehicles and work with potentially dangerous mechanisms. There is no data indicating the effect of Dalatsin C on the ability to drive vehicles and operate machinery.
Dalatsin 100 mg 3 pcs. vaginal suppositories
pharmachologic effect
Antibiotic of the lincosamide group for topical use.
Clindamycin phosphate is not active in vitro, but is rapidly hydrolyzed in vivo to form clindamycin, which has antibacterial activity. Clindamycin inhibits protein synthesis in microbial cells due to interaction with the 50S ribosomal subunit.
In vitro, the following microorganisms that cause bacterial vaginosis are sensitive to clindamycin: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.
Composition and release form Dalatsin 100 mg 3 pcs. vaginal suppositories
Vaginal suppositories are solid, torpedo-shaped, with a smooth surface, white or almost white.
1 sup.:
- Active substance: clindamycin (in phosphate form) - 100 mg;
- Excipients: solid fat (Witepsol H-32, a mixture of triglycerides, diglycerides and monoglycerides) - about 2.4 g.
3 pcs. — strips made of laminated foil — cardboard packs.
3 pcs. — strips made of laminated foil complete with an applicator — cardboard packs.
Directions for use and doses
The recommended dose is 1 suppository intravaginally, preferably at bedtime, for 3 consecutive days.
Pharmacokinetics
Suction
After using clindamycin intravaginally at a dose of 100 mg 1 time / day (in the form of suppositories) for 3 days, approximately 30% (6-70%) of the administered dose of clindamycin is absorbed into the systemic circulation, with an AUC of 3.2 mcg / h / ml (0.42 -11 mcg/h/ml). Cmax in the blood serum is achieved approximately 5 hours (1-10 hours) after administration of the vaginal suppository and averages 0.27 mcg/ml (0.03-0.67 mcg/ml) on the 3rd day of therapy.
The systemic effect of clindamycin when administered intravaginally is significantly weaker than when administered in therapeutic doses orally or intravenously.
Removal
On average, T1/2 is 11 hours (4-35 hours).
Pharmacokinetics in special groups of patients
Clinical studies of clindamycin vaginal suppositories included insufficient numbers of patients aged 65 years and older to evaluate the difference in clinical response to therapy between this age group and younger patients.
Indications for use Dalatsin 100 mg 3 pcs. vaginal suppositories
Bacterial vaginosis.
Contraindications
- hypersensitivity to clindamycin, lincomycin or any component of the drug;
- history of antibiotic-associated colitis;
- age under 18 years (data on safety and effectiveness are not available).
Application of Dalacin 100 mg 3 pcs. vaginal suppositories during pregnancy and breastfeeding
When clindamycin was used intravaginally in the second or third trimester of pregnancy, no increase in the incidence of congenital anomalies of the fetus was observed. If Dalatsin® vaginal suppositories are used during the second or third trimesters of pregnancy (although no official studies have been conducted on the use of suppositories in pregnant women), then an adverse effect on the fetus seems unlikely. The use of the drug in the II-III trimester of pregnancy is possible if the potential benefit to the mother outweighs the risk to the fetus.
There have been no adequate controlled studies on the use of the drug in the first trimester of pregnancy, therefore Dalatsin® vaginal suppositories can be prescribed to women in the first trimester of pregnancy only for absolute indications, i.e. when the potential benefit of drug therapy outweighs the potential risk to the fetus.
In animal studies, when clindamycin was administered subcutaneously or orally, no negative effects on the fetus were found, except when the drug was taken in doses toxic to the mother.
It is unknown whether clindamycin is excreted in breast milk after intravaginal use. Clindamycin is found in breast milk after oral or parenteral administration, therefore, during breastfeeding, the drug should either be discontinued or breastfeeding should be discontinued, taking into account the importance of the drug for the mother.
The use of the drug is contraindicated in people under 18 years of age (data on safety and effectiveness are lacking).
special instructions
Before prescribing the drug, vulvovaginitis caused by Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and the Herpes simplex virus should be excluded using appropriate laboratory methods.
Intravaginal use of clindamycin may lead to increased growth of nonsusceptible microorganisms, especially yeast-like fungi.
The use of clindamycin (like almost all antibiotics) orally or parenterally is associated with the development of severe diarrhea and, in some cases, pseudomembranous colitis. If severe or prolonged diarrhea develops, the drug should be discontinued and, if necessary, appropriate diagnostic and therapeutic measures should be taken.
Patients should be warned that during drug therapy they should avoid sexual intercourse, as well as the use of other means for intravaginal administration (tampons, douching).
The drug contains components that can reduce the strength of latex or rubber products (condoms, contraceptive vaginal diaphragms). Therefore, the use of such products during treatment with Dalatsin and within 72 hours after use is not recommended.
The use of Dalatsin® vaginal suppositories during menstruation is not recommended. The initiation of therapy should be delayed until after menstruation.
Impact on the ability to drive vehicles and operate machinery
The drug does not affect the ability to drive vehicles or engage in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Overdose
With intravaginal use of Dalacin® suppositories, absorption of clindamycin is possible in quantities sufficient to cause systemic reactions.
Accidental exposure of the drug to the gastrointestinal tract may cause systemic effects similar to those that occur after oral administration of clindamycin in therapeutic doses. Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis.
Treatment: symptomatic and supportive therapy.
Side effects Dalacin 100 mg 3 pcs. vaginal suppositories
The safety of clindamycin in the form of vaginal suppositories was assessed in non-pregnant women.
Table. Adverse drug reactions
Often (from ≥1/100 to | Uncommon (≥ 1/1000 to | Frequency unknown (cannot be estimated from available data) |
Infectious and parasitic diseases | ||
Fungal infections, infections caused by fungi of the genus Candida | ||
From the nervous system | ||
Headache | ||
From the digestive system | ||
Abdominal pain, diarrhea, nausea | Vomit | Pseudomembranous colitis |
From the skin and subcutaneous tissues | ||
Itchy skin | Rash | |
From the musculoskeletal system | ||
Side pain | ||
From the urinary system | ||
Pyelonephritis, dysuria | ||
From the reproductive system | ||
Vulvovaginal candidiasis, vulvovaginal pain, vulvovaginal disorders | Vaginal infections, vaginal discharge, menstrual irregularities | |
General disorders and reactions at the injection site | ||
Injection site pain, itching (injection site), localized swelling, pain, pyrexia |
Drug interactions
There is cross-resistance between clindamycin and lincomycin.
Antagonism between clindamycin and erythromycin has been demonstrated in vitro.
It has been established that clindamycin disrupts neuromuscular transmission and, therefore, can enhance the effect of peripherally acting muscle relaxants, so the drug should be used with caution in patients receiving drugs of this group.
Since there is no information on use with other drugs for intravaginal administration, combined use of the drug with other intravaginal drugs is not recommended.
Drug interactions Dalacin c
Cross-resistance exists between clindamycin and lincomycin. also in vitro antagonism between clindamycin and erythromycin. The drug is also incompatible with ampicillin, barbiturates, aminophylline, calcium gluconate, magnesium sulfate. Due to the potential clinical significance of this interaction, these agents should not be coadministered. Concomitant use with antidiarrheal drugs increases the risk of pseudomembranous colitis. Clindamycin has the ability to block neuromuscular transmission and may enhance the effect of other neuromuscular blockers, so the drug should be used with extreme caution in patients prescribed muscle relaxants.